IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs

IDEAL Study : Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs

The principal scientific objective of the trial is to identify the factors that are associated with differential blood pressure responses between drugs. This may allow investigators to produce new hypotheses on the pathophysiology of hypertension and on the mechanisms of drug action.

These factors can be of different types:

• Environmental factors (sodium or alcohol intake);
• Morphological (height, weight, body mass index, body surface area);
• Initial blood pressure;
• Electrocardiogram (ECG) parameters of left ventricular hypertrophy;
• Biological parameters as the activity level of the renin angiotensin aldosterone system;
• Genetic polymorphisms.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Indapamide (T2); Drug: Perindopril (T1); Drug: Placebo of Perindopril (P1); Drug: Placebo of Indapamide (P2)

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • BRon, France, 69677
    • Hôpital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants have to be 25 to 60 years of age
• Both genders
• Systolic blood pressure of 140 mmHg or above; diastolic blood pressure of 90 mmHg or above.
• Cardiovascular risk must not be high, to allow for two periods of 4 weeks of placebo without ethical concern.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2; T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2	Drug: Indapamide (T2); 1.5 mg/day during 4 weeks; Drug: Perindopril (T1); 4 mg/day during 1 week then 8 mg/day during 3 weeks; Drug: Placebo of Perindopril (P1); 1 pill/day during 1 week then 2 pills/day during 3 weeks; Drug: Placebo of Indapamide (P2); 1 pill/day during 4 weeks
Experimental: Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1; T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2	Drug: Indapamide (T2); 1.5 mg/day during 4 weeks; Drug: Perindopril (T1); 4 mg/day during 1 week then 8 mg/day during 3 weeks; Drug: Placebo of Perindopril (P1); 1 pill/day during 1 week then 2 pills/day during 3 weeks; Drug: Placebo of Indapamide (P2); 1 pill/day during 4 weeks
Experimental: Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2; T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2	Drug: Indapamide (T2); 1.5 mg/day during 4 weeks; Drug: Perindopril (T1); 4 mg/day during 1 week then 8 mg/day during 3 weeks; Drug: Placebo of Perindopril (P1); 1 pill/day during 1 week then 2 pills/day during 3 weeks; Drug: Placebo of Indapamide (P2); 1 pill/day during 4 weeks
Experimental: Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2; T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2	Drug: Indapamide (T2); 1.5 mg/day during 4 weeks; Drug: Perindopril (T1); 4 mg/day during 1 week then 8 mg/day during 3 weeks; Drug: Placebo of Perindopril (P1); 1 pill/day during 1 week then 2 pills/day during 3 weeks; Drug: Placebo of Indapamide (P2); 1 pill/day during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure at the end of each 4 week treatment period	Change from baseline and after each 4 week treatment period	16 weeks

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Francois GUEYFFIER, MD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Gueyffier F, Subtil F, Bejan-Angoulvant T, Zerbib Y, Baguet JP, Boivin JM, Mercier A, Leftheriotis G, Gagnol JP, Fauvel JP, Giraud C, Bricca G, Maucort-Boulch D, Erpeldinger S; IDEAL Trial Group. Can we identify response markers to antihypertensive drugs? First results from the IDEAL Trial. J Hum Hypertens. 2015 Jan;29(1):22-7. doi: 10.1038/jhh.2014.29. Epub 2014 Apr 17.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: August 9, 2005
• First Submitted That Met QC Criteria: August 9, 2005
• First Posted (Estimate): August 10, 2005

Study Record Updates

• Last Update Posted (Estimate): January 2, 2012
• Last Update Submitted That Met QC Criteria: December 29, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin-Converting Enzyme Inhibitors; Sodium Chloride Symporter Inhibitors; Perindopril; Indapamide
• Other Study ID Numbers: 2003.340