Study of the efficacy of two blood pressure lowering drugs, ramipril and nifedipine GITS, in reducing the variability of blood pressure in patients with high blood pressure.

REducing blood pressure Variability in Essential hypertension with RAmipril vErsus Nifedipine GITS Trial - REVERENT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003459-76-IT

Enrollment

168

Registered

2014-10-23

Start date

2015-02-03

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

essential hypertension MedDRA version: 17.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: nifedipine GITS Pharmaceutical Form: Modified-release tablet INN or Proposed INN: NIFEDIPINE CAS Number: 21829-25-4 Other descriptive name: NIFEDIPINE GITS Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and female subjects - Age 35-75 years - clinic systolic (SBP) =140 mmHg and/or diastolic blood pressure (DBP) = 90 mmHg - daytime blood pressure (BP) on ambulatory BP monitoring (ABPM) =135 mmHg systolic and/or =85 mmHg diastolic - home SBP standard deviation (SD) >7 mmHg and/or daytime ambulatory SBP SD >12 mmHg - patients may be included if untreated or, if treated with one antihypertensive drug or two drugs in low doses, after 2 weeks’ washout period - written informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68

Exclusion criteria

Exclusion criteria: - subjects treated with = 2 antihypertensive drugs (except those on two drugs in low doses) - treated subjects with on-treatment clinic BP =160 mmHg systolic and/or 100 mmHg diastolic - treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical for other reasons - Contraindications to study treatments as detailed in the relative Summaries of medical Product Characteristics for ramipril or nifedipine GITS (this includes hypersensitivity, pregnancy and lactation) - Cardiovascular diseases other than hypertension - Suspected or confirmed secondary hypertension - Diabetes mellitus - Other conditions deemed relevant by the investigator - BMI =35 kg/m2 - known severe obstructive sleep apnea - Premenopausal women not using effective contraceptive methods - Elevated probability of noncompliance with the study procedures

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effects of nifedipine GITS and ramipril on different estimates of blood pressure variability (over 24 h, at home, between clinic visits) in subjects with elevated blood pressure variability.;Secondary Objective: To assess whether the degree of treatment-induced changes in blood pressure variability, is related to the degree of regression (or progression) of organ damage, after accounting for mean blood pressure reduction by treatment.;Primary end point(s): Variability (standard deviation) of home systolic blood pressure.;Timepoint(s) of evaluation of this end point: Final visit of the main study (10 weeks after randomization)	—

Measure

Time frame

Main Objective: To compare the effects of nifedipine GITS and ramipril on different estimates of blood pressure variability (over 24 h, at home, between clinic visits) in subjects with elevated blood pressure variability.;Secondary Objective: To assess whether the degree of treatment-induced changes in blood pressure variability, is related to the degree of regression (or progression) of organ damage, after accounting for mean blood pressure reduction by treatment.;Primary end point(s): Variability (standard deviation) of home systolic blood pressure.;Timepoint(s) of evaluation of this end point: Final visit of the main study (10 weeks after randomization)

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Secondary

Measure	Time frame
Secondary end point(s): 1) Variability (standard deviation) of home diastolic blood pressure. 2) Short term 24h variability of systolic blood pressure at final visit 3) Short term 24h variability of diastolic blood pressure at final visit 4) Visit-to-visit variability of systolic blood pressure assessed over the three last visits 5) Visit-to-visit variability of diastolic blood pressure assessed over the three last visits 6) Mean 24 hour systolic blood pressure at final visit;Timepoint(s) of evaluation of this end point: Secondary endpoints 1, 2, 3 and 6: Final visit of the main study (10 weeks after randomization) Secondary endpoints 4 and 5: The last three visits of the main study (6, 8 and 10 weeks after randomization)	—

Measure

Time frame

Secondary end point(s): 1) Variability (standard deviation) of home diastolic blood pressure. 2) Short term 24h variability of systolic blood pressure at final visit 3) Short term 24h variability of diastolic blood pressure at final visit 4) Visit-to-visit variability of systolic blood pressure assessed over the three last visits 5) Visit-to-visit variability of diastolic blood pressure assessed over the three last visits 6) Mean 24 hour systolic blood pressure at final visit;Timepoint(s) of evaluation of this end point: Secondary endpoints 1, 2, 3 and 6: Final visit of the main study (10 weeks after randomization) Secondary endpoints 4 and 5: The last three visits of the main study (6, 8 and 10 weeks after randomization)

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Countries

China, Greece, Italy

Contacts

Public ContactScientific Secretariat

Istituto Auxologico Italiano, IRCCS

seg.sci@auxologico.it3902619112894

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026