E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Essential Hypertension |
Essentiel hypertension |
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E.1.1.1 | Medical condition in easily understood language |
Hypertension |
Forhøjet blodtryk |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020772 |
E.1.2 | Term | Hypertension |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is investigating the effect of dietary potassium, nitrate and salt on blood pressure in patients with essential hypertension |
Formålet er at undersøge effekten af kalium, nitrat og salt samt kombinationer heraf i kosten på blodtrykket hos hypertensionspatienter |
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E.2.2 | Secondary objectives of the trial |
To examine thee physiological mechanisms involved in changes in blood pressure after dietary intervention such as sodium and water balance, central hemodynamics, vasoactive hormones, tubular sodium transporters, changes in the immune system and endothelial function |
At undersøge virkningsmekanismerne bag blodtryksændringer ved kostintervention herunder salt- og væskebalancen, central hæmodynamik, vasoaktive hormoner, tubulære natriumtransportere, ændringer i immunsystemet og endothelfunktionen. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Males or females, ≥18 years Body mass index ≤ 35 kg/m2 Essential hypertension (current treatment with a maximum of 3 antihypertensive drugs or newly diagnosed) Capable of adhering to a dietary regimen Albumin-to-creatinine-ratio < 500 mg/g Safe contraception if women in childbearing age eGFR > 60 ml/min/1,73m2
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Kvinder og mænd over 18 år BMI ≤ 35 kg/m2 Essentiel hypertension (aktuel behandling med maksimalt 3 antihypertensiva eller nydiagnosticeret) eGFR > 60 ml/min/1,73m2 Albumin/kreatinin-ratio <500 mg/g Fertile kvinder skal anvende sikker antikonception gennem hele forsøgsperioden, defineret som spiral, hormonel antikonception (p-piller, hormonspiral, implantat, transdermal depotplaster, vaginalring, eller depotinjektion) eller afholdenhed. Undtaget herfra er postmenopausale med udebleven menstruation i mindst 12 måneder før inklusion, kirurgisk steriliserede, kvinder med steriliseret fast partner. I stand til at efterleve kostintervention
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E.4 | Principal exclusion criteria |
Secondary hypertension Clinically significant heart failure (NYHA 3-4) Diabetes mellitus (type 1 and 2) Clinically significant liver disease Current malignant disease (other than skin cancer) Renal transplant Recent stroke, transient ischemic attack or myocardial infarction (past 6 months) Immunosuppressive treatment Pregnancy or lactation Alcohol abuse Nitroglycerin or slow-release nitrate treatment Treatment with other medications that might interact with results and which cannot be paused during the intervention due to safety reasons. CKD due to other cause than hypertension
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Sekundær hypertension f.eks. som følge af nyrearteriestenose, primær hyperaldosteronisme, low-renin hypertension m.fl. Klinisk betydende hjertesvigt (NYHA 3-4) Diabetes mellitus (både type 1 og 2) Klinisk betydende leversygdom Aktiv cancer (fraset spinocellulært og basocellulært karcinom) Nyretransplateret CKD som ikke kan tilskrives hypertension Nylig apopleksi, TCI eller myocardieinfarkt (seneste 6 måneder) I behandling med nitroglycerin eller andre nitratpræparater Fast immunosuppressiv behandling Graviditet eller amning Alkoholoverforbrug Behandling med anden medicin, som vurderes at interferere med forsøgsresultaterne og som af sikkerhedsmæssige grunde ikke kan pauseres i projektperioden. Hvis deltageren efter investigators skøn ikke vurderes egnet til at gennemføre projektperioden.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in systolic 24-hour blood pressure |
Ændring i systolisk døgnblodtryk |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the study, when all participants have completed the trial |
Ved projektets afslutning, når alle deltagere har gennemført |
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E.5.2 | Secondary end point(s) |
Additional 24-hour blood pressure measurements: Diastolic blood pressure, day and night time blood pressure, nocturnal blood pressure decrease. Systemic hemodynamics: central blood pressure, heart frequency, pulse wave velocity and vascular stiffness. Salt-blood test 24 hour urin collection, separated into day and night time for measuring: sodium, potassium, nitrite, nitrate, uric acid, creatinine, osmolality, albumin and the tubular sodium channels ENaC and NCC as well as AQP2. Plasma levels of sodium, potassium, creatinine, uric acid, nitrite, nitrate, ANP, cGMP, aldosterone, renin, angiotensin II, BNP and vasopressin. Plasma levels of IL-1B, IL-6, IL-10, IL-17A and IFN-y.
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Øvrige blodtryksparametre ved døgnblodtryksmåling: diastolisk døgnblodtryk, dagtids- og nattidsblodtryk samt natligt blodtryksfald. Systemisk hæmodynamik: centralt blodtryk (cSBA), hjertefrekvens, pulsbølgehastighed og karstivhed. Salt-blood test (SaBT) Todelt døgnurinopsamling (jf. punkt 9.10) til bestemmelse af udskillelse af natrium, kalium, nitrit, nitrat, karbamid, kreatinin, albumin og osmolalitet samt urinindholdet af de tubulære transportproteiner Epithelial natriumkanal (ENaC), Natriumchlorid cotransporter (NCC), Natrium-kalium-chlorid cotransporter (NKCC) og Aquaporin 2 (AQP2). I plasma måles følgende: natrium, kalium, kreatinin (ud fra denne udregnes den glomerulære filtrationshastighed eGFR), karbamid, nitrit, nitrat og cGMP Plasmaniveauer af vasoaktive hormoner med betydning for vand- og saltbalancen: aldosteron, renin, angiotensin II, atrial natriuretisk peptid (ANP), brain natriuretisk peptid (BNP) og vasopressin. Plasmaniveauer af IL-1B, IL-6, IL-10, IL-17A and IFN-y.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the study, when all participants have completed the trial |
Ved projektets afslutning, når alle deltagere har gennemført |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 8 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |