NCT03168568

Brief Summary

The objective of this study is to evaluate whether valsartan/sacubitril leads to a superior improvement in endothelial function and endocrine status compared to valsartan alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_4 heart-failure

Timeline
Completed

Started May 2017

Typical duration for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

3.3 years

First QC Date

May 22, 2017

Last Update Submit

November 3, 2020

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Difference in flow-mediated vasodilatation (FMD)

    Difference in flow-mediated vasodilatation (FMD, percent dilatation of brachial artery after blood pressure cuff occlusion) between the valsartan/sacubitril and valsartan group as assessed at the final study visit

    Baseline, 3 months

Secondary Outcomes (1)

  • Difference in flicker-induced vasodilatation of retinal arterioles and venules

    Baseline, 3 months

Study Arms (2)

Valsartan/Sacubitril

EXPERIMENTAL

Valsartan-Sacubitril 50mg/100mg twice daily, titrated to 200mg twice daily p.o. Duration of product administration: 3 months

Drug: Valsartan/Sacubitril or placebo

Valsartan

ACTIVE COMPARATOR

Valsartan 40mg/80mg twice daily, titrated to 160mg twice daily p.o Duration of product administration: 3 months

Drug: Valsartan or placebo

Interventions

Valsartan/Sacubitril or placeboDRUG

tablet (double dummy)

Also known as: Entresto®; LCZ696
Valsartan/Sacubitril
Valsartan or placeboDRUG

tablet (double dummy)

Also known as: Diovan®
Valsartan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years of age, male or female, with a diagnosis of symptomatic heart failure (NYHA class II-IV) per ESC heart failure guidelines
  • LVEF ≤ 40%

You may not qualify if:

  • History of hypersensitivity or allergy to any of the study drugs
  • History of angioedema.
  • Sitting systolic blood pressure \<90 mmHg at Visit 1 (screening) or Visit 2 (randomization)
  • Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
  • Estimated GFR \< 20 mL/min/1.73m2
  • Serum potassium \> 5.5 mmol/L at Visit 1 (screening) or Visit 2 (randomization).
  • Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1.
  • Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 3 months after Visit 1.
  • Implantation of a cardiac resynchronization therapy device (CRTD) within 2 months prior Visit 1 or intent to implant a CRTD within next 3 months.
  • History of heart transplant, on a transplant list or with ventricular assistance device (VAD).
  • Presence of significant endocrine diseases.
  • Presence of active acute infectious diseases.
  • Known narrow-angle glaucoma
  • Known epilepsy
  • Cimino-shunt operation on both arms
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Heart Center Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Nagele MP, Haider T, Kreysing L, Barthelmes J, Nebunu D, Rossi VA, Hebeisen M, Sudano I, Ruschitzka F, Flammer AJ. Vascular Endothelial Effects of Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction: Randomized Controlled Trial. JACC Adv. 2024 Nov 13;3(12):101392. doi: 10.1016/j.jacadv.2024.101392. eCollection 2024 Dec.

    PMID: 39606217DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Valsartansacubitrilsacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 30, 2017

Study Start

May 4, 2017

Primary Completion

September 5, 2020

Study Completion

September 5, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

CH(1)