IMPACT-HTN Study of Patients With Hypertension
24. juni 2026 opdateret af: Vivek Bhalla
Prospective Early Patient Experience Initiative (IMPACT-HTN)
An estimated 120 million people have high blood pressure (hypertension) in the US, of which approximately 10% have resistant hypertension.
This study aims to enroll patients who continue to have hypertension while being treated with at least two medications.
The study will follow patients for approximately 3 months and collect real-world information on changes in their health to identify an ideal patient profile that would benefit from 4th-line antihypertensive therapies, including, but not limited to, FDA-approved aprocitentan, renal denervation, mineralocorticoid receptor antagonists, etc.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
To date, there is little multi center data on the management of patients in HTN centers. Elevated blood pressure is the leading global risk factor for death and nonfatal cardiovascular events, primarily strokes, myocardial infarctions, heart failure leading to hospitalization, and end-stage renal disease. After a one-year pilot with two sites, this study plans to expand to additional sites to build a national registry for resistant hypertension research.
This collaborative, prospective study will evaluate the effectiveness and safety of resistant hypertension management, including the use of novel drugs with the aim of defining an ideal patient profile that would benefit from various 4th-line antihypertensive therapies, including, but not limited to, aprocitentan, renal denervation, mineralocorticoid receptor antagonists, etc.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Palo Alto, California, Forenede Stater, 94304
- Stanford University Hypertension Center
-
Kontakt:
- Joel Nicholus, MA
- Telefonnummer: 650-947-7025
- E-mail: nicholus@stanford.edu
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University Hospital
-
Kontakt:
- Krista Camuglia, BSN
- Telefonnummer: 919-862-5967
- E-mail: krista.camuglia@duke.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study population will include 100 patients with inadequately controlled blood pressure despite the use of two therapies.
Beskrivelse
Inclusion Criteria:
- Signed and dated informed consent form
- Ability to answer survey questions and to report blood pressure reading monthly
- Male and female participants; 18 years or older
- Treated with at least 2 antihypertensive therapies of different pharmacological classes for at least 4 weeks before the screening visit
- Mean Sitting Systolic Blood Pressure (SiSBP) greater or equal to 130 mmHg
Exclusion Criteria:
- Confirmed severe hypertension (grade 3) defined as SiSBP greater than or equal to 180 mmHg and/or Sitting Diastolic Blood Pressure (SiDBP) greater than or equal to 110 mmHg
- Clinically significant unstable cardiac disease at screening or in the past in the opinion of the investigator
- Heart failure NYHA functional class III and IV or NT-proBNP > 500 pg/mL
- Severe renal insufficiency or eGFR < 15 mL/min/1.73m2
- Moderate to severe hepatic impairment (Child-Pugh B and C) or elevated aminotransferase (> 3 x ULN)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Difference between exposure groups in change from baseline to Month 3 mean systolic blood pressure
Tidsramme: 90 days
|
90 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline to Month 3 in urine albumin-to-creatinine ratio (UACR) in the overall cohort and between exposure groups
Tidsramme: 90 days
|
90 days
|
|
Interaction between exposure group and baseline albuminuria category on UACR change from baseline to Month 3
Tidsramme: 90 days
|
90 days
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from baseline to Month 3 in routinely collected biomarkers
Tidsramme: 90 days
|
90 days
|
|
Difference between exposure groups in change from baseline to Month 3 biomarker results
Tidsramme: 90 days
|
90 days
|
|
Incidence of edema through Month 3 for the overall cohort
Tidsramme: 90 days
|
90 days
|
|
Comparative incidence of edema; for example, among users of aprocitentan versus unexposed patients
Tidsramme: 90 days
|
90 days
|
|
Comparative incidence of hyperkalemia; for example, among users of mineralocorticoid receptor antagonists vs. unexposed patients
Tidsramme: 90 days
|
90 days
|
|
Incidence of hospitalization due to heart failure through Month 3 for the overall cohort
Tidsramme: 90 days
|
90 days
|
|
Comparative incidence of hospitalizations due to heart failure; for example, among users of aprocitentan versus unexposed patients
Tidsramme: 90 days
|
90 days
|
|
Proportion discontinuing any antihypertensive medication by Month 3 for any reason for the overall cohort
Tidsramme: 90 days
|
90 days
|
|
Comparison of antihypertensive medication discontinuation between exposure groups
Tidsramme: 90 days
|
90 days
|
|
Proportion discontinuing any antihypertensive medication by Month 3 due to edema
Tidsramme: 90 days
|
90 days
|
|
Comparison of antihypertensive medication discontinuation due to edema between exposure groups
Tidsramme: 90 days
|
90 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. april 2027
Studieafslutning (Anslået)
1. april 2027
Datoer for studieregistrering
Først indsendt
6. maj 2026
Først indsendt, der opfyldte QC-kriterier
6. maj 2026
Først opslået (Faktiske)
12. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 86433
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .