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An interventional study on the impact of nocturnal hypertention on the prognosis of heart failure with preserved ejection fraction-a prospective, randomized, praralle controlled study

An interventional study on the impact of nocturnal hypertention on the prognosis of heart failure with preserved ejection fraction-a prospective, randomized, praralle controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106491
Enrollment
Unknown
Registered
2025-07-24
Start date
2024-12-16
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Hypertension, Heart failure

Interventions

A group:Sacubitril/valsartan 100-400mg qn
B group:Sacubitril/valsartan 100-400mg qn and Dapagliflozin 5-10mg qn

Sponsors

The Third People's Hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Hospitalized patients with heart failure whose age >=18 years old. 2. The diagnosis of heart failure is based on the requirements of the 2021 European Heart Association "Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure", "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018" and "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024" on the symptoms, signs and serum markers of heart failure; 3. Left ventricular ejection fraction >=50%, NYHA cardiac function class II-IV. 4. 24-hour ambulatory blood pressure monitoring in the past 4 weeks, with an average blood pressure >=120/70mmHg at night; 5. Volunteer to participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have not signed the informed consent form; 2. For patients with severe liver and kidney insufficiency, ALT/AST/total bilirubin is greater than 3 times that of normal upper line; eGFR<30mL/(min.1.73m^2); 3. Left ventricular ejection fraction < 50%; 4. Patients with refractory hypertension; 5. Female subjects who are pregnant, lactating, or have a positive pregnancy test; 6. Patients with a clear diagnosis of malignant tumors during the screening inclusion period or intervention follow-up period; 7. Those who have undergone or are expected to undergo ventricular synchronization therapy or left heart assist device within 3 months; 8. Patients with clearly diagnosed obstructive sleep apnea syndrome; 9. Diagnosed with perinatal or chemotherapy-induced cardiomyopathy within 3 months before the screening inclusion period; 10. Acute coronary syndrome, stroke, transient ischemic attack, major cardiac or carotid surgery, such as coronary artery bypass grafting, percutaneous coronary intervention, or carotid angioplasty in the first 3 months of the screening period.

Design outcomes

Primary

MeasureTime frame
All cause death or Cardiovascular death ;Heart failure rehospitalization;

Secondary

MeasureTime frame
Control rate of nocturnal hypertension;Unspecified cardiovascular events, i.e. stroke, severe arrthymia, renal failure etc;

Countries

China

Contacts

Public ContactGang Huang

The Third People's Hospital of Chengdu

oigg22@126.com+86 28 6133 2288

Outcome results

None listed

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