NCT04715698

Brief Summary

A single-center, single-blind, randomized study to investigate the effectiveness of a hemodynamic-guided treatment strategy to improve blood pressure control

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable hypertension

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

December 31, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

January 11, 2021

Last Update Submit

January 16, 2021

Conditions

Hypertension

Keywords

HypertensionICG-guidedHemodynamic profilingImpedance cardiography

Outcome Measures

Primary Outcomes (2)

  • Change from baseline systolic blood pressure at 8 weeks

    Change from baseline systolic blood pressure at 8 weeks in the window of 4-12 weeks

    8 weeks post-baseline

  • Change from baseline diastolic blood pressure at 8 weeks

    Change from baseline diastolic blood pressure at 8 weeks in the window of 4-12

    8 weeks post-baseline

Secondary Outcomes (6)

  • BP control rate at 8 weeks

    8 weeks post-baseline

  • Change from baseline heart rate (HR) at 8 weeks

    8 weeks post-baseline

  • Change from baseline cardiac index (CI) at 8 weeks

    8 weeks post-baseline

  • Change from baseline arterial stiffness (AS) at 8 weeks

    8 weeks post-baseline

  • Change from baseline systemic vascular resistance index (SVRI) at 8 weeks

    8 weeks post-baseline

  • +1 more secondary outcomes

Study Arms (2)

ICG-guided

EXPERIMENTAL

anti-hypertensive drug selection based on physician's experience and hemodynamic profiling by measured ICG

Other: ICG-guided drug selection

Empirical

ACTIVE COMPARATOR

anti-hypertensive drug selection based on physician's experience only

Other: empirical drug selection

Interventions

ICG-guided drug selectionOTHER

anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience

ICG-guided
empirical drug selectionOTHER

anti-hypertensive drug selection based on physician's experience only

Empirical

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • office BP \>= 140/90 mmHg
  • hypertensive patients who were treatment naive or previously treated with 1-3 anti-hypertensives
  • age 18-85, males or females
  • agree to sign informed consent

You may not qualify if:

  • having unstable hemodynamics diseases, or had myocardial infarction (MI), heart failure (HF) or chronic kidney disease (CKD) within previous 6 months
  • using large doses of diuretics or beta-blockers (usually refers to double max doses) and can not stop dosing
  • atrial fibrillation (AF) or severe arrhythmia
  • severe aortic regurgitation
  • severe thoracic fluids
  • height weight out of ranges: 120-230 cm30-230 kg
  • using more than 3 antihypertensives
  • known secondary hypertension
  • refused to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

Related Publications (1)

  • Lu Y, Wang L, Wang H, Gu J, Ma ZJ, Lian Z, Zhang Z, Krumholz H, Sun N. Effectiveness of an impedance cardiography guided treatment strategy to improve blood pressure control in a real-world setting: results from a pragmatic clinical trial. Open Heart. 2021 Sep;8(2):e001719. doi: 10.1136/openhrt-2021-001719.

    PMID: 34580169DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ningling Sun

    Department of Hypertension at Heart Centr, Peking University People's Hospital, Beijing, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Hypertension Department at Heart Center

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 20, 2021

Study Start

December 31, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)