A pilot study regarding efficacy and safety of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes

A pilot study regarding efficacy and safety of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes - A pilot study of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004059

Enrollment

Registered

2010-09-01

Start date

2010-09-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic heart failure combined with hypertension and diabetes

Interventions

Add Aliskiren 150mg/day (up to 300mg/day) to Valsartan 80mg/day for 24 weeks Add Amlodipine 2.5mg/day (up to 5mg/day) to Valsartan 80mg/day for 24 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. chronic heart failure combined with hypertension and type 2 diabetes 2.serum BNP equal to or more than 100mg/dl 3. SBP equal to or more than 130 or DBP equal to or more than 80mmHg in hospital (or SBP equal to or more than 125 or DBP equal to or more than 75mmHg on home blood pressure monitoring) after 4 weeks of Valsartan 80mg/day administration during observation period 4. Serum creatinine less than 3.0mg/dl

Exclusion criteria

Exclusion criteria: 1. Within 24 weeks after initiation of statin, fibrates, or diabetes drug other than insulin 2. Within 24 weeks after onset of acute myocardial infarction 3. Within 12 weeks after onset of stroke 4. Severe ventricular arrhythmia or AV block (second or third degree) 5. Cardiogenic shock 6. Secondary hypertension other than renal hypertension 7. Bilateral renal artery stenosis 8. Hypertensive emergency including malignant hypertension 9. Severe liver damage 10. Severe hemopoietic disorder or malignancy 11. Type 1 diabetes 12. During Cyclosporine administration 13. During pregnancy or lactation. Woman of child-bearing potential

Design outcomes

Primary

Measure	Time frame
Serum brain natriuretic peptide level (After 12 and 24 weeks)	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026