Clinical trial NCT01030458: Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
Official title: Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Pressure
Keywords: Blood pressure
Hypertension
Blacks
Africa
Blood pressure control
Side-effects
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University of Kinshasa
name: Yaounde Central Hospital
name: University of Yaounde
name: University of Libreville
name: Institute of Cardiology Abidjan
name: University of Ilorin Teaching Hospital
name: University of Nigeria, Enugu Campus
name: Hospital Aristide Le Dantec, Dakar, Senegal
First posted: 2009-12-11
Enrollment: 183
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.

Detailed description: Primary objective:

Sitting systolic blood pressure (average of three readings) will be the primary outcome variable.

Secondary

1. To compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic;
2. To compare the duration of follow-up, during which a steady blood pressure control will be achieved;
3. To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups;
4. To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.

Eligibility criteria: Inclusion Criteria:

* Women or men within an age range from 30 to 69 years with uncomplicated hypertension.
* Blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the European Societies of Hypertension and Cardiology.
* Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of three readings obtained immediately after the patient has assumed a standing position).
* Patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. If two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm Hg systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs.
* The patient must provide informed written consent.

Exclusion Criteria:

* Premenopausal women not applying anticonception.
* A history of cardiovascular disease.
* Secondary hypertension.
* Electrocardiographic left ventricular hypertrophy.
* More than two cardiovascular risk factors in addition to hypertension.
* Diabetes mellitus.
* Renal dysfunction.
* Recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks.
* Severe non-cardiovascular disease.
* Known contra indications for the first-line study medications.

Primary outcomes:
measure: Sitting Systolic Blood Pressure on Automated Measurement
timeFrame: 6 months follow-up after randomization
Secondary outcomes:
measure: Time to Blood Pressure Control
timeFrame: 6 months follow-up after randomization
measure: Side-effects to Study Medications
timeFrame: 6 months follow-up after randomization
measure: Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up
timeFrame: 6 months follow-up after randomization
Other outcomes:
Locations:
city: Douala
country: Cameroon
facility: Ecole de Médecine de Douala
city: Yaoundé
country: Cameroon
facility: Hôpital Général de Yaoundé
city: Abidjan
country: Côte D'Ivoire
facility: Institut de Cardiologie d'Abidjan
city: Libreville
country: Gabon
facility: Hôpital Central Universitaire de Libreville
city: Enugu
country: Nigeria
facility: University of Enugu
city: Ilorin
country: Nigeria
facility: University of Ilorin
city: Dakar
country: Senegal
facility: Hôpital Aristide Le Dantec
Study officials:
affiliation: Hôpital Général de Yaoundé, BP 5408, Yaoundé, Cameroun
name: Samuel Kingue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Douala, Douala, Cameroon
name: Daniel Lemogoum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Central Universitaire de Libreville, Libreville, Gabon
name: Bruno Mipinda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ilorin, Ilorin, Nigeria
name: Omotoso Babatunde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Enugu, Enugu, Nigeria
name: Ifeoma E Ulasi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Aristide Le Dantec, Dakar, Sénégal
name: Serigne Abdou Ba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kinshasa, Kinshasa, Democratic Republic of Congo
name: Jean-René M'Buyamba-Kabangu, MD, PhD
role: STUDY_CHAIR
affiliation: University of Leuven, Leuven, Belgium
name: Jan A Staessen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Odili AN, Richart T, Thijs L, Kingue S, Boombhi HJ, Lemogoum D, Kaptue J, Kamdem MK, Mipinda JB, Omotoso BA, Kolo PM, Aderibigbe A, Ulasi II, Anisiuba BC, Ijoma CK, Ba SA, Ndiaye MB, Staessen JA, M'buyamba-Kabangu JR; NOAAH Investigators. Rationale and design of the Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) trial. Blood Press. 2011 Oct;20(5):256-66. doi: 10.3109/08037051.2011.572614. Epub 2011 Apr 15.
citation: M'Buyamba-Kabangu JR, Anisiuba BC, Ndiaye MB, Lemogoum D, Jacobs L, Ijoma CK, Thijs L, Boombhi HJ, Kaptue J, Kolo PM, Mipinda JB, Osakwe CE, Odili A, Ezeala-Adikaibe B, Kingue S, Omotoso BA, Ba SA, Ulasi II, Staessen JA; Newer versus Older Antihypertensive Agents in African Hypertensive Patients Trial (NOAAH) Investigators. Efficacy of newer versus older antihypertensive drugs in black patients living in sub-Saharan Africa. J Hum Hypertens. 2013 Dec;27(12):729-35. doi: 10.1038/jhh.2013.56. Epub 2013 Jun 27.
citation: Osakwe CE, Jacobs L, Anisiuba BC, Ndiaye MB, Lemogoum D, Ijoma CK, Kamdem MM, Thijs L, Boombhi HJ, Kaptue J, Kolo PM, Mipinda JB, Odili AN, Ezeala-Adikaibe B, Kingue S, Omotoso BA, Ba SA, Ulasi II, M'buyamba-Kabangu JR, Staessen JA; Newer Versus Older Antihypertensive Agents in African Hypertensive Patients Trial (NOAAH) Investigators. Heart rate variability on antihypertensive drugs in black patients living in sub-Saharan Africa. Blood Press. 2014 Jun;23(3):174-80. doi: 10.3109/08037051.2013.836810. Epub 2013 Sep 25.
citation: Odili AN, Ezeala-Adikaibe B, Ndiaye MB, Anisiuba BC, Kamdem MM, Ijoma CK, Kaptue J, Boombhi HJ, Kolo PM, Shu EN, Thijs L, Staessen JA, Omotoso BA, Kingue S, Ba SA, Lemogoum D, M'Buyamba-Kabangu JR, Ulasi II. Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients. Trials. 2012 May 17;13:59. doi: 10.1186/1745-6215-13-59.